Respiratory InsufficiencyPhase 3BMWNCT00473148
B-type Natriuretic Peptide for the Management of Weaning
A Phase 3 study testing BNP-guided weaning and Standard physician-directed weaning in people with Respiratory Insufficiency, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Several clinical findings and clinical trials have suggested that the prognosis of intensive care unit (ICU) patients may be improved by minimizing the positive fluid balance. In particular, a global vascular overload could lead to weaning failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Insufficiency
- What is being tested?
- BNP-guided weaning and Standard physician-directed weaning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 265 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2007to Mar 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Intubated patient receiving mechanical ventilation for at least 24 hours
- SpO2 ≥ 90% with FiO2 ≤ 50% and PEP ≤ 8 cm H2O
- Hemodynamic stability without vasopressor therapy (dopamine ≤ 10 γ/kg/min and dobutamine ≤ 10 γ/kg/min are however allowed) nor fluid bolus (rapid infusion of at least 500 ml of macromolecules or 1000 ml of saline) during the twelve previous hours
- Sedation stopped or reduced during the previous 48 hours (analgesia may be continued)
- Stable neurological status with Ramsay score ≤ 5
- Body temperature > 36.0 °C and < 39 °C
- Informed consent signed by patient or close relative
Who cannot join
- I: Definite exclusion criteria:
- Pregnancy or lactation
- Age < 18 years
- Known allergy to furosemide or sulphonamides
- Tracheotomy on inclusion
- Hepatic encephalopathy
Show all 16Show fewer
- Cerebral edema, acute hydrocephaly
- Myasthenia gravis or acute idiopathic polyradiculoneuritis (Guillain-Barré syndrome)
- Decision to withdraw life support
- Prolonged cardiac arrest with poor neurological prognosis
- II: Temporary exclusion criteria:
- Extubation of the patient programmed for the same day
- Acute right ventricular insufficiency (pulmonary embolism, right myocardial infarction)
- Renal insufficiency defined by one of the following: renal replacement therapy, or plasma urea > 25 mmol/L, or plasma creatinine > 180 µmol/L, or creatinine clearance < 30 mL/min or increase by more than 25% of plasma creatinine during the previous 24 hours
- One of the following metabolic abnormalities: blood sodium > 150 mEq/L; blood potassium < 3.5 mEq/L; metabolic alkalosis with arterial pH > 7.50
- Injection of iodinated contrast agent during the preceding six hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Weaning of Mechanical Ventilation Guided by the Natriuretic Peptide of Type B
Several clinical findings and clinical trials have suggested that the prognosis of intensive care unit (ICU) patients may be improved by minimizing the positive fluid balance. In particular, a global vascular overload could lead to weaning failure. The purpose of this international, multicenter, controlled, randomized trial is to test if the incorporation of a B-type natriuretic peptide (BNP) assay in a mechanical ventilation weaning protocol helps optimize the weaning process and reduce the duration of the ventilatory weaning period.
Read the detailed description
Mechanical ventilation may give rise to complications with an incidence that increases with the duration of respiratory support. The purpose of the weaning procedure is to reduce the duration of mechanical ventilation without incurring a substantial risk of failure. Several clinical findings and clinical trials have suggested that the prognosis of ICU patients may be improved by minimizing the positive fluid balance. In particular, a global vascular overload could lead to weaning failure. B-type natriuretic peptide (BNP) is a hormone secreted by the ventricular cardiomyocytes in response to increased wall stretch, and its plasma levels are correlated with left ventricular filling pressure. In a preliminary study on 102 patients undergoing weaning from mechanical ventilation, the baseline BNP levels before weaning were found to be an independent risk factor for weaning failure. In surviving patients, BNP levels were significantly correlated with the duration of weaning procedure. The purpose of this international, multicenter, controlled, randomized trial is to test if the incorporation of a BNP assay in a mechanical ventilation weaning protocol helps optimize the weaning process and reduce the duration of ventilatory weaning period. Patients on mechanical ventilation presenting weaning criteria will be randomly assigned to two groups (standard physician-directed weaning or weaning guided by BNP assay). In order to standardize the weaning process, patients will be ventilated with an automatic computer-driven weaning system in the two groups (EVITA Smart Care System, Drager Medical). A blood sample will be collected from all patients every morning for BNP assay by the rapid immunofluorescence test (Triage BNP Test, BIOSITE). In the control group, the clinician will not be informed about the assay results and weaning will be carried out according to usual practices. Patients in the intervention group will receive diuretics according to a clinical practice algorithm based on plasma BNP levels and a fluid intake restriction. The primary endpoint for the two groups will be duration of weaning from mechanical ventilation.
- Conditions
- Respiratory Insufficiency
- Being tested
- BNP-guided weaning, Standard physician-directed weaning
- Keywords
- Duration of weaning from invasive ventilation, Mechanical ventilation, Weaning, B-type natriuretic peptide, Fluid balance, Diuretics, Intubated patient receiving mechanical ventilation, for at least 24 hours, Respiratory insufficiency
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNP-guided weaningProcedure or surgery
BNP-guided weaning
Standard physician-directed weaningProcedure or surgery
Standard physician-directed weaning
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | BNP-guided treatment (Furosemide) Receives: Procedure: BNP-guided weaning |
| 2 | No intervention | Not described Receives: Procedure: Standard physician-directed weaning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of weaning from invasive ventilation
Measured: during ventilation
Secondary outcomes (7)
Total duration of weaning from invasive and noninvasive ventilation
Measured: during hospitalisation
Total duration of mechanical ventilation
Measured: during hospitalisation
Length of stay in the ICU, length of stay in hospital, number of complications in intensive care, number of prolonged weanings (> 15 days), number of cases of nosocomial pneumonia, number of successful extubations, extubation complication rates
Measured: during hospitalisation in ICU
Cost of stay in the ICU
Measured: in the ICU
Cost of stay in hospital
Measured: during the all stay
Mortality in ICU
Measured: in ICU
Mortality sixty days after randomization
Measured: sixty days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2007 (estimated)
- Study startJun 2007
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Dräger Médical S.A, Abbott RDx Cardiometabolic
- Investigators
- Armand Mekonto Dessap, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00473148
- Sponsor's protocol ID
- P051018
- Acronym
- BMW
- Status last verified
- Nov 2008
- First submitted
- 11 May 2007
- Last updated
- 30 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Dessap AM, Roche-Campo F, Launay JM, Charles-Nelson A, Katsahian S, Brun-Buisson C, Brochard L. Delirium and Circadian Rhythm of Melatonin During Weaning From Mechanical Ventilation: An Ancillary Study of a Weaning Trial. Chest. 2015 Nov;148(5):1231-1241. doi: 10.1378/chest.15-0525.
PubMed 26158245Mekontso Dessap A, Katsahian S, Roche-Campo F, Varet H, Kouatchet A, Tomicic V, Beduneau G, Sonneville R, Jaber S, Darmon M, Castanares-Zapatero D, Brochard L, Brun-Buisson C. Ventilator-associated pneumonia during weaning from mechanical ventilation: role of fluid management. Chest. 2014 Jul;146(1):58-65. doi: 10.1378/chest.13-2564.
PubMed 24652410Mekontso Dessap A, Roche-Campo F, Kouatchet A, Tomicic V, Beduneau G, Sonneville R, Cabello B, Jaber S, Azoulay E, Castanares-Zapatero D, Devaquet J, Lellouche F, Katsahian S, Brochard L. Natriuretic peptide-driven fluid management during ventilator weaning: a randomized controlled trial. Am J Respir Crit Care Med. 2012 Dec 15;186(12):1256-63. doi: 10.1164/rccm.201205-0939OC. Epub 2012 Sep 20.
PubMed 22997204
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weaning of Mechanical Ventilation Guided by the Natriuretic Peptide of Type B
- ClinicalTrials.gov ID
- NCT00473148
- Acronym / sponsor ID
- BMW / P051018
- Conditions
- Respiratory Insufficiency
- Keywords
- Duration of weaning from invasive ventilation, Mechanical ventilation, Weaning, B-type natriuretic peptide, Fluid balance, Diuretics, Intubated patient receiving mechanical ventilation, for at least 24 hours
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Dräger Médical S.A, Abbott RDx Cardiometabolic
- Study start
- Jun 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 14 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Several clinical findings and clinical trials have suggested that the prognosis of intensive care unit (ICU) patients may be improved by minimizing the positive fluid balance. In particular, a global vascular overload could lead to weaning failure. The purpose of this international, multicenter, controlled, randomized trial is to test if the incorporation of a B-type natriuretic peptide (BNP) assay in a mechanical ventilation weaning protocol helps optimize the weaning process and reduce the duration of the ventilatory weaning period.
Detailed description
Mechanical ventilation may give rise to complications with an incidence that increases with the duration of respiratory support. The purpose of the weaning procedure is to reduce the duration of mechanical ventilation without incurring a substantial risk of failure. Several clinical findings and clinical trials have suggested that the prognosis of ICU patients may be improved by minimizing the positive fluid balance. In particular, a global vascular overload could lead to weaning failure. B-type natriuretic peptide (BNP) is a hormone secreted by the ventricular cardiomyocytes in response to increased wall stretch, and its plasma levels are correlated with left ventricular filling pressure. In a preliminary study on 102 patients undergoing weaning from mechanical ventilation, the baseline BNP levels before weaning were found to be an independent risk factor for weaning failure. In surviving patients, BNP levels were significantly correlated with the duration of weaning procedure. The purpose of this international, multicenter, controlled, randomized trial is to test if the incorporation of a BNP assay in a mechanical ventilation weaning protocol helps optimize the weaning process and reduce the duration of ventilatory weaning period. Patients on mechanical ventilation presenting weaning criteria will be randomly assigned to two groups (standard physician-directed weaning or weaning guided by BNP assay). In order to standardize the weaning process, patients will be ventilated with an automatic computer-driven weaning system in the two groups (EVITA Smart Care System, Drager Medical). A blood sample will be collected from all patients every morning for BNP assay by the rapid immunofluorescence test (Triage BNP Test, BIOSITE). In the control group, the clinician will not be informed about the assay results and weaning will be carried out according to usual practices. Patients in the intervention group will receive diuretics according to a clinical practice algorithm based on plasma BNP levels and a fluid intake restriction. The primary endpoint for the two groups will be duration of weaning from mechanical ventilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: BNP-guided weaningBNP-guided treatment (Furosemide) |
| 2 | No intervention | Procedure: Standard physician-directed weaning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Intubated patient receiving mechanical ventilation for at least 24 hours
- SpO2 ≥ 90% with FiO2 ≤ 50% and PEP ≤ 8 cm H2O
- Hemodynamic stability without vasopressor therapy (dopamine ≤ 10 γ/kg/min and dobutamine ≤ 10 γ/kg/min are however allowed) nor fluid bolus (rapid infusion of at least 500 ml of macromolecules or 1000 ml of saline) during the twelve previous hours
- Sedation stopped or reduced during the previous 48 hours (analgesia may be continued)
- Stable neurological status with Ramsay score ≤ 5
Key exclusion criteria (16 listed)
- Pregnancy or lactation
- Age < 18 years
- Known allergy to furosemide or sulphonamides
- Tracheotomy on inclusion
- Hepatic encephalopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BNP-guided weaningBNP-guided weaning | Procedure or surgery | 1 |
| Standard physician-directed weaningStandard physician-directed weaning | Procedure or surgery | 2 |
Primary outcome
Duration of weaning from invasive ventilation
Time frame: during ventilation
7 secondary outcomes
Total duration of weaning from invasive and noninvasive ventilation
Time frame: during hospitalisation
Total duration of mechanical ventilation
Time frame: during hospitalisation
Length of stay in the ICU, length of stay in hospital, number of complications in intensive care, number of prolonged weanings (> 15 days), number of cases of nosocomial pneumonia, number of successful extubations, extubation complication rates
Time frame: during hospitalisation in ICU
Cost of stay in the ICU
Time frame: in the ICU
Cost of stay in hospital
Time frame: during the all stay
Mortality in ICU
Time frame: in ICU
Mortality sixty days after randomization
Time frame: sixty days after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2010.
- Derived from this study: PubMed 26158245Dessap AM, Roche-Campo F, Launay JM, Charles-Nelson A, Katsahian S, Brun-Buisson C, Brochard L. Delirium and Circadian Rhythm of Melatonin During Weaning From Mechanical Ventilation: An Ancillary Study of a Weaning Trial. Chest. 2015 Nov;148(5):1231-1241. doi: 10.1378/chest.15-0525.
- Derived from this study: PubMed 24652410Mekontso Dessap A, Katsahian S, Roche-Campo F, Varet H, Kouatchet A, Tomicic V, Beduneau G, Sonneville R, Jaber S, Darmon M, Castanares-Zapatero D, Brochard L, Brun-Buisson C. Ventilator-associated pneumonia during weaning from mechanical ventilation: role of fluid management. Chest. 2014 Jul;146(1):58-65. doi: 10.1378/chest.13-2564.
- Derived from this study: PubMed 22997204Mekontso Dessap A, Roche-Campo F, Kouatchet A, Tomicic V, Beduneau G, Sonneville R, Cabello B, Jaber S, Azoulay E, Castanares-Zapatero D, Devaquet J, Lellouche F, Katsahian S, Brochard L. Natriuretic peptide-driven fluid management during ventilator weaning: a randomized controlled trial. Am J Respir Crit Care Med. 2012 Dec 15;186(12):1256-63. doi: 10.1164/rccm.201205-0939OC. Epub 2012 Sep 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armand Mekonto Dessap, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BNP-guided weaning and Standard physician-directed weaning in people with Respiratory Insufficiency, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of weaning from invasive ventilation (time frame: during ventilation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00473148, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2010.